Inflatable penile implant

ABSTRACT

A body implantable penile prosthetic assembly includes a pump and a release mechanism. The pump is connectable to a pressure reservoir and a penile implant, where the pressure reservoir contains a pressurized liquid at a first pressure when implanted. The release mechanism is connectable between the pressure reservoir and the penile implant and is configured to release the pressurized liquid from the pressure reservoir to inflate the penile implant to a second pressure that is less than the first pressure. The pump is operable to transfer the pressurized liquid from the penile implant to the pressure reservoir to deflate the penile implant, and pressurize the pressurized liquid in the pressure reservoir from the second pressure to at least the first pressure.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes one or more cylinders that areimplanted in the corpora cavernosa of the penis, a liquid reservoirimplanted in the abdomen that communicates with the cylinder(s), and apump, often located in the scrotum, that is employed to move liquid fromthe liquid reservoir into the cylinder(s).

In a typical application, the user squeezes a bulb of the pump multipletimes to incrementally draw liquid out of the liquid reservoir, into thebulb, and eventually into the cylinders. The repeated squeezing of thebulb moves the liquid from the reservoir into the cylinders, whichincrementally deflates the reservoir and incrementally inflates thecylinder(s) to eventually provide the user with an erect penis. The usermay return the penis to its flaccid state by selectively transferringthe liquid from the cylinder(s) back into the reservoir.

The above-described penile prosthetics have proven effective inrelieving erectile dysfunction in men. However, men have expressed acontinuing desire for more spontaneous, efficient, and effective penileprostheses.

SUMMARY

One aspect provides a body implantable penile prosthetic assemblyincluding a pump and a release mechanism. The pump is connectable to apressure reservoir and a penile implant, where the pressure reservoircontains a pressurized liquid at a first pressure when implanted. Therelease mechanism is connectable between the pressure reservoir and thepenile implant and is configured to release the pressurized liquid fromthe pressure reservoir to inflate the penile implant to a secondpressure that is less than the first pressure. The pump is operable totransfer the pressurized liquid from the penile implant to the pressurereservoir to deflate the penile implant, and pressurize the pressurizedliquid in the pressure reservoir from the second pressure to at leastthe first pressure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of a body implantable penile prostheticassembly including a pump connected to a pressure reservoir and a penileimplant according to one embodiment.

FIG. 2 is a perspective view of the pump illustrated in FIG. 1.

FIG. 3 is a cross-sectional view of the pump illustrated in FIG. 2showing a release mechanism.

FIG. 4A is a side view of a transverse value of the release mechanismillustrated in FIG. 3 according to one embodiment.

FIG. 4B is a side view of a seal of the release mechanism illustrated inFIG. 4A.

FIG. 5 is a cross-sectional view of the pump in a configuration suitedto pressurize the pressure reservoir illustrated in FIG. 1.

FIG. 6 is a cross-sectional view of the pump in a configuration forimmediately inflating the penile implant illustrated in FIG. 1.

FIG. 7 is a cross-sectional view of the pump in a configuration fordeflating the penile implant illustrated in FIG. 1.

FIG. 8A is a schematic view of the body implantable penile prostheticassembly implanted in a man.

FIG. 8B is a schematic graph of pressure-volume characteristics of thepressure reservoir of the body implantable penile prosthetic assemblyillustrated in FIG. 8A.

FIG. 9 is a perspective view of a body implantable penile prostheticassembly including a pump connected between a liquid reservoir and apressure reservoir both of which communicate with a penile implantaccording to one embodiment.

FIG. 10 is a cross-sectional view of the pump illustrated in FIG. 9.

FIG. 11A is a cross-sectional view of a release mechanism of theassembly illustrated in FIG. 9.

FIG. 11B is a cross-sectional view of the release mechanism illustratedin FIG. 11A in an inflation state.

FIG. 12 is a block diagram of a method of achieving an erection in amale provided with a body implantable penile prosthetic assembly.

FIG. 13 is a perspective view of the body implantable penile prostheticassembly illustrated in FIG. 9 with the pressure reservoir pressurizedaccording to one embodiment.

FIG. 14 is a perspective view of the body implantable penile prostheticassembly illustrated in FIG. 9 with the pressure reservoir depressurizedand the penile implant inflated according to one embodiment.

FIG. 15 is a schematic view of two embodiments of a body implantablepenile prosthetic assembly.

FIG. 16 is a side view of a pressure reservoir disposed inside of aliquid reservoir according to one embodiment of a body implantablepenile prosthetic assembly.

FIG. 17 is a side view of a pressure reservoir connected side-by-side toa liquid reservoir according to one embodiment of a body implantablepenile prosthetic assembly.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” as employed in this application means that thereferenced part is situated next to or near the point of attachment ororigin or a central point: as located toward a center of the human body.The term “distal” as employed in this application means that thereferenced part is situated away from the point of attachment or originor the central point: as located away from the center of the human body.A distal end is the furthest endmost location of a distal portion of athing being described, whereas a proximal end is the nearest endmostlocation of a proximal portion of the thing being described. Forexample, the glans penis is located distal, and of the crus of the penisis located proximal relative to the male body such that a distal end ofa corpora cavernosum of the patient extends about midway into the glanspenis.

“Fluid” means a non-solid substance that flows and includes gases andliquids, or a combination of a gas and a liquid.

“Gas” means a substance having molecules that disperse and are free toexpand to occupy an entire volume of a container in which it isdisposed. Air and methyl butane are two examples of gases.

“Liquid” means a substance having molecules that do not disperse suchthat the liquid resists compression and the molecules of the liquid willnot disperse to fill all spaces of a container in which the liquid isdisposed. Saline is an example of a liquid.

“Immediate” in this Specification is employed in the context ofinflating a penile implant and means that the implant is inflatable toan erect state in a time of less than about 5 seconds. Thus, an“immediately inflatable penile implant” is a penile implant thatinflates in less than 5 seconds to provide the penis with an erection.In one embodiment, the penile implant inflates in about 2 seconds toprovide the penis with nearly instantaneous erection.

Atmospheric pressure at sea level is approximately 14 pounds per squareinch (PSI). The pressure measured or referred to as regards thepressurized liquid in the penile prosthetic assembly described herein isin reference to a gauge pressure, which is a pressure that has beenincreased above atmospheric pressure. This gauge pressure is recorded aspounds per square inch gauge (PSIg).

Embodiments provide a body implantable penile prosthetic assembly havinga pressure reservoir that allows the implant to be immediatelyinflatable, or in other words, be inflatable with one-touch user input(sometimes referred to as “one-up” inflatable). In one embodiment, thepressure reservoir is pressurized prior to intimate relations and arelease mechanism that releases pressurized liquid from the pressurereservoir to immediately inflate the penile implant for a more naturaland spontaneous erection of the penis.

The prosthetic assembly of the embodiments described herein isconfigured to inflate the penile implant to an erect state within 5seconds or so, which stands in stark contrast to the known prostheticassemblies that become incrementally erect over a time frame fromone-half to several minutes. The pressure reservoir is configured to bepressurized above atmospheric pressure, and the pump is configured toincrease the pressure in the pressure reservoir; thus, the pressure inthe pressure reservoir is not constant, but is user-adjustable toprepare for expected relations in cases where an immediate erection ofthe penis is desirable. In such cases, the increased pressure in thepressure reservoir is released to the implant via the release mechanism.

FIG. 1 is a perspective view of a penile prosthetic assembly 20according to one embodiment. The penile prosthetic assembly 20 includesa pump 22 connected to a pressure reservoir 24 and a penile implant 26,and a release mechanism 28 connected between the pressure reservoir 24and the penile implant 26. Generally, the pump 22 is implanted into thescrotum of the user, the pressure reservoir 24 is implanted within theabdomen of the user, and the implant 26 is implanted within the penis.

In one embodiment, the penile prosthetic assembly 20 is implanted as asealed system with the reservoir 24 pressurized to an initial pressureabove atmospheric pressure, for example between 20-30 PSIg, andconnected in a sealed manner to the other components of the assembly 20.The release mechanism 28 is configured to release the pressurized liquidfrom the pressure reservoir 24 to inflate the penile implant 26 to apressure between 10-20 PSIg, which is less than the initial pressure. Inone embodiment, for example, the reservoir 24 pressurized to an initialpressure between 20-29 PSIg to inflate the penile implant 26 to apressure of 15 PSIg. That is to say the system of the implanted assembly20 is not a constant pressure system, but the reservoir 24 is insteadconfigured to be pressure-adjustable by the user to provide an inflationpressure that is sufficient to inflate the implants 26. When the implant26 is inflated, the reservoir 24 and the implant 26 are pressurized toan equilibrium pressure in the range of 10-20 PSIg.

The pump 22 is operable to transfer the pressurized liquid from thepenile implant 26 back to the pressure reservoir 24 to deflate thepenile implant and also to pressurize the pressurized liquid in thepressure reservoir 24 back to between 20-30 PSIg. The pump 22 increasespressure in a liquid that is contained in the pressure reservoir 24 andthe release mechanism 28 releases pressurized liquid from the pressurereservoir 24 to the penile implant 26 at a pressure that is configuredto make the penile implant 26 erect.

The increased pressure in the pressure reservoir 24 can be maintainedfor several hours. The increased pressure in the pressure reservoir 24is releasable on demand via the release mechanism 28 to transfer thepressurized liquid from the pressure reservoir 24 to the implant 26,which will result in the rapid inflation of the implant 26 to an erectstate. As a point of reference in FIG. 1, the pressure reservoir 24 isillustrated in a pressurized state that is “primed” to immediatelyinflate the flaccid implant 26 upon activation of the release mechanism28.

The pressure reservoir 24 is connected to the pump 22 via kink resistanttubing 30 and contains a liquid and such as water or saline. In oneembodiment, the assembly 20 is hermetically sealed (i.e., the pump 22does not pump air) with a sufficient amount of liquid in the reservoir24 to inflate the implant 26 without undesirably accessing the assembly20 to inject more liquid. The pump 22 is operable to increase thepressure of the liquid in the sealed pressure reservoir 24, and thepressure reservoir 24 is configured to expand and provide a pressurizedsystem configured to immediately inflate the penile implant 26 oncommand from the user. In one embodiment, the pressure reservoir 24 is aflexible bladder having walls that expand as the liquid in the pressurereservoir 24 is pressurized. The expanded walls of the pressurereservoir 24 store potential energy for subsequent release to theimplant 26.

The pressure reservoir 24 is sized to hold a volume of liquid betweenabout 50-350 ml. In one embodiment, the pressure reservoir 24 isprovided as a cylindrical reservoir formed from an elastic, flexiblepolymer with a wall thickness of between 0.010-0.060 inches. Oneexemplary embodiments of the reservoir 24 has a wall thickness of about0.025 inches thick, formed of a polyurethane polymer, and so configuredto have walls that expand to store potential energy created when thepump 22 increases the pressure of the liquid in the pressure reservoir24. In one embodiment, the reservoir 24 is provided as a “cloverleaf”style of reservoir (as illustrated in FIG. 13) having multiple leavesthat may be folded one against the other to compactly fold the pressurereservoir 24 for implantation into the abdomen of the user. One suitablereservoir 24 is sized to contain approximately 130 ml of liquid and isavailable from Coloplast Corp., Minneapolis, Minn.

In one embodiment, the penile implant 26 includes a pair of inflatablecylinders 32 that are sized to be implanted into the penis, and each ofthe cylinders 32 is connected to the pump 22 by kink resistant tubes 34.Each of the cylinders 32 includes a proximal end 36 opposite a distalend 38. During implantation, the proximal end 36 (also called a reartip) is implanted toward the crus of the penis and the distal end 38 isimplanted within the glans penis. The cylinders 32 are fabricated frommaterial configured to collapse and be flexible when the cylinders 32are deflated to provide the penis with a flaccid state and expand whenthe cylinders 32 are inflated with liquid to provide the penis with anerection. Suitable material for fabricating the cylinders 32 includessilicone, polymers such as urethanes, blends of polymers with urethane,copolymers of urethane, or the like. Suitable cylinders are availablefrom Coloplast Corp., Minneapolis, Minn.

FIG. 2 is a perspective view of the pump 22. The pump 22 includes a pumpbulb 40 connected to a pump body 42 that houses the release mechanism28. The pump body 42 has a pair of inflation ports 44 that connect withthe cylinders 32 via the tubes 34 (FIG. 1), and an exhaust port 46 thatconnects with the pressure reservoir 24 via the tube 30. The pump 22 isfabricated from material suitable for body implantation, such assilicone or the urethane-based materials described above for thecylinders 32 or the reservoir 24.

In one embodiment, the release mechanism 28 is integrated within thepump body 42. The pump body 42 is deformable and includes a first touchpad 50 opposite a second touch pad 52. The touch pads 50, 52 may have acircular shape or a non-circular (e.g., elliptical) shape, and othershapes for the touch pads 50, 52 are also acceptable. The pump body 42houses or maintains valves (described below) that are activateddeactivated by pressing one or both of the touch pads 50, 52. In oneembodiment, the pads 50, 52 are configured for one-touch deformation ofthe pump body 42 such that finger pressure applied to one of the pads50, 52 by the implant user deforms the pump body 42 to allow pressurizedliquid to flow around one or more of the internal valves.

In one embodiment, the pump bulb 40 is flexible and includes a pleatedaccordion structure that allows the pump bulb 40 to collapse andrecover. The pump bulb 40 is operable to drive liquid into the pressurereservoir 24, or further pressurize the liquid in the pressure reservoir24, or deflate the implant 26. For example, the pump bulb 40 isconfigured to reversibly collapse and recover to move liquid through thepump 22 or to pressurize the liquid that has collected in the pressurereservoir 24. When the cylinders 32 are inflated, the pump bulb 40 isoperable to pump the liquid from the inflated cylinders 32, through thepump body 42 and the pump bulb 40, out of the exhaust port 46 and backinto the pressure reservoir 24.

FIG. 3 is a cross-sectional view of the pump 22. With refer ice to FIG.2, the cross-section of FIG. 3 has been taken through the pump body 42between the two inflation ports 44. Thus, the inflation port 44 is inthe background and is not shown in cross-section.

The pump 22 includes a deflation valve 54 disposed within the pump body42 that communicates between the implant 26 (FIG. 1) and the pump bulb40, an exhaust valve 56 disposed within the pump body 42 thatcommunicates between the pump bulb 40 and the pressure reservoir 24, anda transverse valve 60 disposed in the pump body 42 between the deflationvalve 54 and the exhaust valve 56. In one embodiment, the deflationvalve 54 is aligned axially between the pump bulb 40 and the inflationports 44, the exhaust valve 56 is aligned axially between the pump bulb40 and the exhaust port 46, and the transverse valve 60 is transverse tothe deflation valve 54 and the exhaust valve 56.

The deflation valve 54 includes a ball 70 that is biased into contactwith a surface 72 by a spring 74. The ball 70 is configured to bedisplaced from the surface 72 (thus compressing the spring 74) when thepump bulb 40 applies suction, in which case liquid flows from theimplant 26 through the inflation ports 44 and into the pump bulb 40. Thespring 74 biases the ball 70 into contact with the surface to block theflow of the liquid from the pressurized implant 26 to the bulb 40. Inthis manner, the deflation valve 54 is a one-way valve.

The exhaust valve 56 includes a ball 80 that is biased into contact witha surface 82 by a spring 84. The ball 80 is configured to be displacedfrom the surface 82 (thus compressing the spring 84) when liquid ispushed from the pump bulb 40 through the exhaust valve 56 toward thepressure reservoir 24. For example, compressing the pump bulb 40 ejectsliquid from the pump bulb 40, which unseats the ball 80 from the surface82 to allow the liquid to flow past the ball 80 and the transverse valve60 into the pressure reservoir 24. Repeatedly squeezing the pump bulb 40will pressurize the liquid in the pressure reservoir 24. The spring 84biases the ball 80 into contact with the surface 82 to block backflow ofliquid from the pressure reservoir 24 into the pump bulb 40. In thismanner, the exhaust valve 56 is provided as a one-way exhaust valve.

In one embodiment, the pump body 42 is an elastomeric chamber 86 moldedaround the transverse valve 60. The pump body 42 is deformable such thatwhen the touch pads 50, 52 are squeezed, the chamber 86 molded aroundthe transverse valve 60 is displaced away from the valve 60, whichallows pressurized liquid to flow from the pressure reservoir 24 pastthe transverse valve 60 and into the cylinders 32 for immediateinflation of the cylinders (FIG. 6). In one embodiment, when the touchpads 50, 52 are squeezed, only the transverse valve 60 is “opened”(valves 54 and 56 are not opened) to allow the pressurized liquid toflow between the transverse valve 60 and the molded chamber 86 and intothe cylinders 32 for immediate inflation of the cylinders. In oneembodiment, the pump body 42 is silicone having a Shore-A hardness ofbetween 10-65 Shore-A, for example.

FIG. 4A is a side view of the transverse valve 60. The transverse valve60 includes a valve stem 90, a flange 92 disposed on a first end ofportion 94 of the valve stein 90, a seal 96, a spring 98 that biases theseal 96 away from the flange 92 toward a second end portion 100 of thevalve stein 90, and a crown 102 attached to the valve stein 90 oppositethe flange 92. In one embodiment, the spring 98 is a conical springhaving a base 104 that interacts with the flange 92 and an end 106 thatinteracts with the seal 96. The base 104 is wider than the end 106.

With reference to FIG. 3, the second end portion 100 of the valve stem90 and the crown 102 cooperate to seal the pressurized liquid within thepressure reservoir 24 until the pads 50, 52 (FIG. 3) are touched todeform the chamber 86. The second end portion 100 and the crown 102maintain the “primed” status of the pressure reservoir 24, which allowsthe user to pressurize the pressure reservoir 24 ahead of expected useof the implant 26 in its erect state. That is to say, the user maypressurize the pressure reservoir 24 to its primed state several minutesor hours or longer before “use” of the implant 26, and with one touch tothe pads 50, 52, the user is able to inflate the implant 26 to achieve anearly spontaneous erection.

FIG. 4B is a side view of the seal 96. In one embodiment, the seal 96 isconical seal having a wider end 107 oriented toward the flange 92 and anarrower end 109 oriented toward the second end portion 100. The conicalspring 98 is mated into the wider conical end 107 of the seal 96.

The wider end 107 is configured to block or deny the escape of thepressurized liquid from flowing from the pressurized implant 26 (FIG. 1)transverse through the pump body 42 and back to the pressure reservoir24 until the pads 50, 52 (FIG. 3) are touched to deform the chamber 86.With reference to FIG. 3, the wider end 107 of the seal 96 of thetransverse valve 60 is biased by the spring 98 to prevent pressurizedliquid from flowing from the pressurized implant 26 into the pressurereservoir 24. The pressurized liquid in the implant 26 forces the widerend 107 of the seal 96 toward the second end portion 100 of the valvestem 90 to close off the flow path in the direction of the exhaust port46. Thus, the implant 26 will remain pressurized and erect until theuser selectively deflates the implant 26 by pumping the bulb 40.

FIGS. 5-7 illustrate various configurations of the pump 22. Reference ismade to FIG. 1 in the following description of FIGS. 5-7.

FIG. 5 is a cross-sectional view of the pump 22 configured forpressurization of the pressure reservoir 24. Squeezing the pump bulb 40moves the liquid in the assembly 20 into the pressure reservoir 24. Whenthe pump bulb 40 is compressed, the liquid in the pump bulb 40 isejected through the exhaust valve 56 along the pathway P, displacing theball 80 away from its seat on a surface 82. The liquid is forced alongthe pathway P under the crown 102 of the transverse valve 60, throughthe exhaust port 46, and into the pressure reservoir 24.

In one embodiment, when the pump bulb 40 is squeezed, liquid movingthrough the exhaust valve 56 forces the crown 102 of the transversevalve 60 upward to prevent the liquid that is flowing toward thepressure reservoir 24 from being diverted transversely through the pumpbody 42 toward the implant 26. Subsequent multiple pumps of the pumpbulb 40 pressurizes the liquid in the pressure reservoir 24. Thetransverse valve 60 seals off the pressurized liquid in the pressurereservoir 24 and maintains the assembly 20 in the primed status readyfor immediate inflation of the implant 26. In one embodiment, thetransverse valve 60 maintains the assembly 20 in the primed status withthe pressure reservoir 24 pressurized above atmospheric pressure, anduseful such pressures in the pressure reservoir 24 are between about10-50 PSIg as an example.

FIG. 6 is a cross-sectional view of the pump 22 showing theconfiguration during immediate inflation of the implant 26. When a userdesires to achieve an erection, the touch pads 50, 52 are pressed todislodge the crown 102 (FIG. 4A) and create a liquid path around thecrown 102 co-axially along the valve stem 90 and to separate the seal 96from the chamber 86 molded around the transverse valve 60. Dislodgingthe seal 96 and the crown 102 provides the pressurized liquid in thepressure reservoir 24 with a pathway I through the pump body 42 thatallows the pressurized liquid to flow directly into the implant 26. Thetubing 30, 34 will hold a relatively small volume of liquid as comparedto the pressure reservoir 24, such that, the pressure in implant 26 isless than about 20-30 PSIg when the pressurized liquid occupies theimplant 26. In one embodiment, the implant 26 is inflated to a pressurebetween 0-20 PSIg, and preferably the implant 26 is inflated to apressure of about 15 PSIg. It has been determined that the pressureconfigured to inflate the penile implant to an erect state is about 0-20PSIg.

FIG. 7 is a cross-sectional view of the pump 22 configured for deflationof implant 26. The assembly 20 allows the user to selectively deflatethe implant 26 by operating the pump bulb 40. For example, when theimplant 26 is an inflated (erect) state and filled with pressurizedliquid, pumping the pump bulb 40 will create suction in the bulb 40 thatdraws the liquid from the implant 26 along the pathway D through thedeflation valve 54 and into the pump bulb 40. Subsequent pumping of thebulb 40 pushes the liquid through the exhaust valve 56 back into thepressure reservoir 24. During deflation of the implant 26, thetransverse valve 60 is shunted upward to block the transverse flowwithin the pump body 42 between the exhaust port 46 and the inflationport 44. Thus, the liquid moved through the pump bulb 40 will exit theimplant 26, flow through the pump bulb 40 and under the crown 102, andback into the pressure reservoir 24.

FIG. 8A is a schematic side view of the penile prosthetic assembly 20implanted in a user. The cylinders 32 are implanted in the penis P withthe proximal end 36 inserted near the crus and the distal end 38implanted within the glans. The reservoir 24 is implanted within theabdomen A and the pump 22 is implanted within the scrotum S. The penileprosthetic assembly 20 is operable consistent with the description aboveto immediately inflate the cylinders 32 by releasing pressurized liquidfrom the pressure reservoir 24 by activation of the release mechanism28.

In one embodiment, the assembly 20 is implanted by the surgeon andprimed by filling the pressure reservoir 24 with an appropriate volumeof liquid, for example between about 100-300 ml as an example. In oneembodiment, the liquid in the pressure reservoir 24 is pressurized tobetween about 20-50 PSIg when implanted. The assembly 20 is sealed toprovide a closed system, and the pump 22 and the release mechanism 28are employed to selectively transport the pressurized liquid in theassembly 20 between the pressure reservoir 24 and the implant 26.

In one embodiment, a method of providing a user with the inflatablepenile prosthetic assembly 20 includes providing a pump 22 attachable toa pressure reservoir 24 and a penile implant 26; configuring thepressure reservoir 24 to store pressurized liquid PL; and configuringthe pressure reservoir 24 to release the pressurized liquid PL from thepressure reservoir 24 to the penile implant 26 at a pressure that isconfigured to inflate the penile implant to an erect state.

In one embodiment, the method provides a user with an immediate erectionor an erection that is spontaneous enough to mimic a natural erection.The immediate erection is achieved by first increasing pressure in theliquid in the pressure reservoir 24 to a first pressure aboveatmospheric pressure, for example 20-30 PSIg. This pressure level isachieved either by the surgeon initially pressurizing the reservoir 24,or later, by the user employing the pump 22 to adjust the pressure levelin the pressure reservoir. This pressure level in the pressure reservoir24 may be maintained for minutes or up to several hours or more,depending upon user preference. When the user determines that the timeis appropriate to achieve an erection, the touch pads 50, 52 areactivated to release the pressurized liquid PL from the pressurereservoir 24 directly into the implant 26. In one embodiment, theimplant 26 is pressurized at a second pressure of about 10-20 PSIg,which is less than the pressurization of the pressure reservoir 24(e.g., due to line losses in the assembly 20), but sufficient tomaintain an erection in the implant 26.

Releasing the pressurized liquid PL from the pressure reservoir 24 intothe implant 26 by touching the pads 50, 52 will result in thepressurized liquid PL moving rapidly into the implant 26. In oneembodiment, the implant 26 is moved from the flaccid state to an erectstate in a matter of a few seconds, for example less than about 5seconds. The erect/inflated implant 26 is deflated by pumping the bulb40 to transfer the liquid in the implant 26 back into the pressurereservoir 24.

FIG. 8B is a schematic graph of pressure-volume characteristics of thepressure reservoir of the body implantable penile prosthetic assembly 20as illustrated in FIG. 8A. The pressure reservoir 24 is pressurized to a“primed” pressure condition of 30 PSIg in this example. Thus, thepressure reservoir 24 has a relatively high volume of liquid (it isessentially full) and a relatively high primed pressure of 30 PSIg. Thepressurized liquid is released for the pressure reservoir 24 to theimplant 26, which inflates the implant 26 to a pressure of about 15 PSIgin this example and likewise drops the pressure in the pressurereservoir 24 to about 15 PSIg. The implant 26 is deflated by pumping thebulb 40, which transfers the liquid back into the pressure reservoir 24,and with additional pumping of the bulb 40, increases the pressure inthe pressure reservoir 24 back up to about 30 PSIg, as an example. Thus,the pressure reservoir 24 is not a constant pressure reservoir.

FIG. 9 is a perspective view of a penile prosthetic assembly 400according to one embodiment. The penile prosthetic assembly 400 includesa pump 402 connected between a pressure reservoir 404, a liquidreservoir 406, and the penile implant 26, and has a release mechanism408 separate from the pump 402 and connected between the pressurereservoir 404 and the penile implant 26.

The liquid reservoir 406 is shown containing an amount of liquid (i.e.,inflated), and the pressure reservoir 404 and the implant 26 are shownin a deflated state. The pump 402 is provided to transfer the liquidfrom the liquid reservoir 406 into the pressure reservoir 404, and toadditionally pressurize the liquid in the pressure reservoir 404 between20 and 30 PSIg to provide a primed system ready for immediate inflationof the implant 26. The release mechanism 408 maintains the primed statusof the system by preventing the pressurized liquid in the pressurereservoir 404 from escaping until the user initiates inflation of theimplant 26. When the release mechanism 408 is activated, the pressurizedliquid in the pressure reservoir 404 is released to rapidly flow intoand create an erection in the implant 26.

In one embodiment, the implant 26 includes the cylinders 32 describedabove. A first tube 110 is connected between the liquid reservoir 406and the pump 402, a second tube 112 is connected between the pump 402and the pressure reservoir 404, and a pair of tubes 114 is connectedbetween the pressure reservoir 404 and the cylinders 32. In oneembodiment, a single tube connects between the pressure reservoir 404and the release mechanism 408, and a pair of tubes extends from therelease mechanism 408 to the implants 26.

FIG. 10 is a cross-sectional view of one embodiment of the pump 402. Thepump 402 includes a pump bulb 120 connected to a pump body 122 thathouses an inlet valve 124 and an outlet valve 126. In one embodiment,the pump bulb 120 and the pump body 122 are molded from a flexiblepolymer such a silicone, although other polymers are also acceptable. Inone embodiment, the inlet valve 124 is provided as a one-way valveincluding a ball 130 that is biased against a surface 132 by a spring134. In one embodiment, the outlet valve 126 is provided as a one-wayvalve including a ball 140 that is biased against a surface 142 by aspring 144. The bulb 120 is operable to draw liquid from the liquidreservoir 406 through the tube 110, which displaces the ball 130 fromthe surface 132 and allows the liquid to flow into the bulb 120.Additional pumping of the bulb 120 pushes the ball 140 away from thesurface 142 and forces the liquid through the tube 112 into the pressurereservoir 404. In one embodiment, subsequent pumping of the bulb 120increases the pressure of the liquid in the pressure reservoir 404.

It is desirable that the assembly 400 is provided as a closed system. Inone embodiment, the liquid reservoir 406 is filled with liquid (e.g.,saline) and the assembly 400 is charged to an initial pressure ofbetween 20-30 PSIg, for example. In this manner, air and other gases aresealed from the assembly 400.

In one embodiment, the pressure reservoir 404 is provided as a flexiblebladder that expands when pressurized to store the potential energy ofthe pressurized liquid. The release mechanism 408 is provided to releasethe stored potential energy inside of the pressure reservoir 404, whichis employed to inflate the implant 26.

FIG. 11A is a cross-sectional view of the release mechanism 108 closedand configured to maintain the pressure reservoir 404 in the pressurizedstate. In one embodiment, the release mechanism 408 includes thetransverse valve 60 (as described above) positioned between an inletport 150 that communicates with the tube 114 connected to the pressurereservoir 404 and an outlet port 152 that communicates with tubingconnected to the implant 26. The transverse valve 60 is described aboveand functions to seal off or close the pathway of the pressurized liquidin the pressure reservoir 404 until the user activates the releasemechanism 408. In particular, the transverse valve 60 is provided withthe seal 96 that is biased into a closed position against a surface 154of a chamber 156 by the spring 98. In one embodiment, the chamber 156 isflexible or deformable to allow the surface 154 to be moved away fromthe seal 96 to allow the pressurized liquid in the pressure reservoir404 to flow axially along the valve stem 90 and inflate the implant 26.

FIG. 11B is a cross-sectional view of the release mechanism 408 in aninflation state. In one embodiment, the transverse valve 60 is disposedwithin a housing 160 provided with one or more touch pads 162. The touchpads 162 are configured to be pressed by a finger or fingers of the userto compress the housing 160 and to deform the chamber 156 such that theseal 96 is not in contact with the surface 154. The deformation in thechamber 156 provides a liquid pathway I that allows the pressurizedliquid to flow from the pressure reservoir 404 directly and immediatelyto the implant 26. The crown 102 (FIG. 4A) seals the return path tocontain the pressurized liquid within the implant 26.

Embodiments of the assembly 400 allow a user of the penile implant 26 toselectively and immediately achieve an erect penis by first priming thepressure reservoir 404 of the system to an increased pressure and thensubsequently releasing on demand the increased pressure from thepressure reservoir 404 to the implant 26.

FIG. 12 is a block diagram 170 of a method of achieving an immediateerection in a male user provided with a body implantable penileprosthetic assembly. The method includes preparing for future expectedrelations at 172 and moving liquid from a liquid reservoir to pressurereservoir at 174. The method further includes pressurizing the liquid inthe pressure reservoir at 176 and storing the pressurized liquid in thepressure reservoir at 178. The pressurized liquid in the pressurereservoir may be stored for several hours. When a user of the implantdesires to achieve an erection, the method provides an option to act onthe expected relations at 180 by releasing the pressurized liquid fromthe pressure reservoir to the penile implant at a pressure that inflatesthe implant to an erect state at 182. The method allows the user todeflate the implant at 184.

There are instances when the user, after having pressurized the pressurereservoir at 176 and storing the pressurized liquid in the pressurereservoir at 178, no longer desires to achieve an erection. The methodprovides the user with the option to not act on expected relations at190 by releasing the pressurized liquid from the pressure reservoir backto the liquid reservoir at 192.

FIG. 13 is a perspective view of the penile prosthetic assembly 100showing the liquid reservoir 406 deflated after the liquid in thereservoir 406 has been moved into the pressure reservoir 404 (nowinflated). The implant 26 remains in a deflated state.

FIG. 14 is a perspective view of the penile prosthetic assembly 400showing the liquid reservoir 406 deflated after emptying its contentsinto the pressure reservoir 404, and the liquid pressure between thepressure reservoir 404 and the implant 26 equalized, which partiallydeflates the pressure reservoir 404 and fully inflates the implants 26.

FIG. 15 is a schematic view of the relationship between the bodyimplantable penile prosthetic assembly 20 (FIG. 1) and the bodyimplantable penile prosthetic assembly 100 (FIG. 9) according to oneembodiment. The assembly 400 includes the liquid reservoir 406 andprovides the pump 402 that transfers the liquid from the liquidreservoir 406 into the pressure reservoir 404. In contrast, the assembly20 of FIG. 1 includes the pressure reservoir 24 containing a volume ofpressurized liquid and a release mechanism 28 that releases thepressurized liquid from the pressure reservoir 24 to the implant 26. Inthis sense, the assembly 20 is a subset of the assembly 400, where bothassemblies 400 provide a solution for erectile dysfunction.

FIG. 16 is a side view of one embodiment of a penile prosthetic assembly200 including a pump 202 connected to a pressure reservoir 204 that isdisposed inside of a liquid reservoir 206, and having a releasemechanism 208 connected between the pressure reservoir 204 and thepenile implant 26.

FIG. 17 is a side view of one embodiment of the penile prostheticassembly 300 including a pump 302 connected to a pressure reservoir 304that is connected to a side of the liquid reservoir 306, and having arelease mechanism 308 connected between the pressure reservoir 304 andthe penile implant 26.

Although specific embodiments have been illustrated and describedherein, will be appreciated by those of ordinary skill in the art that avariety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

1. A body implantable penile prosthetic assembly comprising: a pumpprovided with a pressure reservoir and a penile implant, the pumpconfigured to be connected to the pressure reservoir and the penileimplant, the pump operable to pressurize liquid in the pressurereservoir and the pressure reservoir operable to store the pressurizedliquid at a first pressure that is configured to inflate the penileimplant to an erect state; and a release mechanism configured to beconnected between the pressure reservoir and the penile implant andconfigured to release the stored pressurized liquid from the pressurereservoir to inflate the penile implant at a second pressure that isless than the first pressure; wherein the pump is operable to transferliquid from the penile implant to the pressure reservoir to deflate thepenile implant and the first pressure of the pressurized liquid storedin the pressure reservoir is between 20-50 PSIg and the second pressureis between 10-20 PSIg.
 2. The assembly of claim 1, wherein the penileprosthetic assembly is sealed when implanted to prevent addingadditional liquid, and the pressure reservoir comprises walls that areconfigured expand to store potential energy created when the pumpincreases pressure of the liquid in the pressure reservoir.
 3. Theassembly of claim 1, wherein the pump comprises a bulb attached to apump body and the release mechanism is integrated with the pump body. 4.The assembly of claim 3, wherein the pump comprises a deflation valvedisposed in the pump body that is operable to transfer the pressurizedliquid from the penile implant to the pressure reservoir, and therelease mechanism comprises a transverse valve disposed in the pump bodytransverse to the deflation valve and a seal that is biased to retainthe pressurized liquid in the pressure reservoir.
 5. The assembly ofclaim 4, wherein the pump body is deformable to displace the seal toallow the pressurized liquid in the pressure reservoir to flowco-axially alongside the transverse valve to the penile implant.
 6. Theassembly of claim 5, wherein the pump body comprises a touch pad that isoperable to deform the pump body with one touch.
 7. The assembly ofclaim 3, wherein the pump further comprises: an exhaust valve disposedin the pump body, the bulb operable to move liquid through the exhaustvalve to the pressure reservoir and pressurize the pressurized liquid inthe pressure reservoir.
 8. The assembly of claim 1, further comprising:a liquid reservoir configured to be connected between the pump and thepressure reservoir, the pump configured to transfer liquid from theliquid reservoir to the pressure reservoir and pressurize the liquidtransferred into the pressure reservoir.
 9. A body implantable penileprosthetic assembly comprising: a penile implant; a liquid reservoir; apressure reservoir; a pump connected between the liquid reservoir andthe pressure reservoir and configured to transfer liquid from the liquidreservoir to the pressure reservoir; a release mechanism separate fromthe pump and connected between the pressure reservoir and the penileimplant; wherein the pump pressurizes the liquid in the pressurereservoir and the release mechanism releases pressurized liquid from thepressure reservoir to the penile implant at a pressure that isconfigured to make the penile implant erect.
 10. The penile prostheticassembly of claim 9, wherein the pump increases pressure of the liquidin the pressure reservoir to a first pressure and the release mechanismreleases the pressurized liquid from the pressure reservoir at a secondpressure that is less than the first pressure.
 11. The penile prostheticassembly of claim 10, wherein the first pressure in the pressurereservoir is in a range of 20-50 PSIg and the second pressure in thepenile implant is in a range of 10-20 PSIg.
 12. The penile prostheticassembly of claim 10, wherein the pressure reservoir is configured toretain the pressurized liquid at the first pressure for more than 1 hourand the release mechanism releases the pressurized liquid from thepressure reservoir upon a one-touch command.
 13. The penile prostheticassembly of claim 12, wherein the release mechanism comprises a checkvalve that releases the pressurized liquid from the pressure reservoirinto the penile implant to produce an immediate erection.
 14. The penileprosthetic assembly of claim 13, wherein the check valve is reversibleto release the pressurized liquid from the penile implant to thepressure reservoir to deflate the penile implant.
 15. The penileprosthetic assembly of claim 9, wherein the pump comprises a bulb thatis compressible to transfer the liquid from the liquid reservoir to thepressure reservoir.
 16. The penile prosthetic assembly of claim 9,wherein the pressure reservoir comprises a flexible bladder.
 17. Thepenile prosthetic assembly of claim 16, wherein the flexible bladder isextensible to store potential energy of the pressurized liquidtransferred to the pressure reservoir and compressible to transfer thepotential energy into kinetic energy of moving liquid employed to makethe penile implant erect.
 18. The penile prosthetic assembly of claim 9,wherein the pump comprises a valve disposed in a deformable valvehousing, and deforming the deformable valve housing allows thepressurized liquid in the pressure reservoir to flow back into theliquid reservoir.
 19. The penile prosthetic assembly of claim 18,wherein the pump comprises two valves disposed in a deformable valvehousing.
 20. The penile prosthetic assembly of claim 19, wherein thepressure reservoir is attached to a side of the liquid reservoir. 21.The penile prosthetic assembly of claim 19, wherein the pressurereservoir is disposed inside of the liquid reservoir.